Roles & Responsibility
Perform and review Equipment Qualification activities (IQ, OQ, PQ).
Manage and monitor HVAC qualification and validation activities.
Handle Stability Studies and ensure compliance with regulatory requirements.
Execute Installation Qualification and Temperature Mapping for storage areas and equipment.
Perform Process Validation and prepare validation protocols and reports.
Prepare, review, and maintain Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Conduct Laboratory QA (Lab QA) activities and ensure compliance with GMP/GLP requirements.
Review and investigate Laboratory Investigations (Lab Investigations), including OOS, OOT, deviations, and CAPA.
Participate in internal and external audits, ensuring audit readiness and timely closure of observations.




Perform Empower data review and ensure data integrity in accordance with regulatory guidelines.
Ensure compliance with cGMP, SOPs, and applicable regulatory standards.

Preferred Candidate Profile

The ideal candidate should have hands-on experience and sound knowledge of:
Equipment Qualification (IQ/OQ/PQ)
HVAC Qualification
Stability Studies
Installation Qualification
Temperature Mapping
Process Validation
Preparation and review of BMR & BPR
Laboratory Quality Assurance (Lab QA)
Laboratory Investigation (OOS/OOT, Deviations, CAPA)
Audit preparation, participation, and compliance
Empower software review and data integrity practices
Positive Manufacturing Practices (cGMP) and regulatory requirements

📌 Quality Assurance Executive, Senior Executive And Deputy Manager Pithampur
🏢 Piramal Pharma
📍 Pithampur